A case study of a severe cholestatic syndrome induced by danazol, with
ultrastructural description of liver morphology, is reported. Cholest
asis appeared after 3 months treatment with danazol (300 mg/daily) and
completely resolved 2 months after withdrawal. In spite of the severe
increase in serum bilirubin and total serum bile salts, transaminases
were only slightly elevated and GGT and alkaline phosphatases were al
most normal. Light microscopy shows a pattern of predominantly centrol
obular cholestasis without necrosis, with minimal inflammaton/infiltra
te and with no sign of bile ductule involvement. At the ultrastructura
l level very dilated bile canaliculus predominate with stunted or loss
of microvilli and dense bile material in the lumen. Nonspecific alter
ations were seen in hepatocyte intracellular organelles. It is suggest
ed that danazol may cause a rare but severe hepatocanalicular cholesta
sis, differing from the ''bland'' cholestasis frequently described dur
ing therapy with other anabolic steroids.